Total-Body Irradiation, Cyclophosphamide, and Stem Cell Transplantation in Treating Patients With Hematologic Cancer
This study has been completed.
Sponsor:
Fred Hutchinson Cancer Research Center
Collaborator:
Information provided by:
Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier:
NCT00062140
First received: June 5, 2003
Last updated: September 20, 2010
Last verified: September 2010
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Purpose
RATIONALE: Adjusting the dose of drugs used in chemotherapy such as cyclophosphamide may decrease side effects while stopping cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. Stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy and radiation therapy used to kill cancer cells.
PURPOSE: Phase I trial to study the effect on the body of dose-adjusted cyclophosphamide combined with total-body irradiation and donor stem cell transplantation in treating patients who have hematologic cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia Lymphoma Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases |
Drug: cyclophosphamide Procedure: allogeneic bone marrow transplantation Procedure: peripheral blood stem cell transplantation Radiation: radiation therapy |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I Trial Of Total Body Irradiation, Cyclophosphamide Dose-Adjustment Based On Its Metabolism, And Hematopoietic Stem Cell Transplantation For Patients With Hematological Malignancy |
Resource links provided by NLM:
Genetics Home Reference related topics:
familial acute myeloid leukemia with mutated CEBPA
mycosis fungoides
Sézary syndrome
MedlinePlus related topics:
Acute Myeloid Leukemia
Bone Marrow Transplantation
Cancer
Chronic Myeloid Leukemia
Leukemia
Lymphoma
Myelodysplastic Syndromes
Drug Information available for:
Cyclophosphamide
U.S. FDA Resources
Further study details as provided by Fred Hutchinson Cancer Research Center:
| Study Start Date: | April 2003 |
| Study Completion Date: | July 2004 |
OBJECTIVES:
- Determine a safe and reproducible method of adjusting the dose of cyclophosphamide based on its metabolism when given in combination with total body irradiation and hematopoietic stem cell transplantation in patients with hematologic malignancy.
OUTLINE:
- Preparative regimen: Patients undergo total body irradiation twice daily on days -6 to -4. Patients then receive dose-adjusted (based on metabolism) cyclophosphamide IV over 1 hour on days -3 and -2.
- Hematopoietic stem cell (HSC) infusion: Patients undergo allogeneic HSC transplantation on day 0.
Patients receive graft-versus-host disease prophylaxis, CNS prophylaxis, and testicular irradiation as per institutional standard practices.
Patients are followed daily until day 80 after transplantation and then regularly thereafter for survival.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
Diagnosis of hematological malignancy, including any of the following:
- Chronic myeloid leukemia
- Acute myeloid leukemia
- Acute lymphocytic leukemia
- Myelodysplastic syndromes
- Lymphoma
- Unlikely to respond to conventional treatment and would benefit from hematopoietic stem cell transplantation
- No bulky tumor mass requiring additional involved field radiotherapy
- No large body burden of tumor cells requiring cytoreductive chemotherapy before total body irraditation and cyclophosphamide
- Undergoing conditioning for transplantation at the University of Washington Medical Center
Availability of 1 of the following types of allogeneic donors:
- HLA-identical family members
Unrelated donors
- Allele match (match grade 1)
- One allele mismatch for A, B, C, DRB1 or DQB1 (match grades 2.1 or 2.2)
PATIENT CHARACTERISTICS:
Age
- 18 to 65
Performance status
- Not specified
Life expectancy
- Not severely limited by diseases other than malignancy
- Not moribund
Hematopoietic
- Not specified
Hepatic
- Bilirubin no greater than 1.2 mg/dL
- No cirrhosis
- No hepatic fibrosis with bridging
Renal
- Creatinine no greater than 1.2 mg/dL
Cardiovascular
- No coronary artery disease
- No congestive heart failure requiring therapy
Pulmonary
- Oxygen saturation at least 93% (on room air)
Other
- Not pregnant or nursing
- Fertile patients must use effective contraception
- HIV negative
- No concurrent infection requiring systemic antibiotic or antifungal therapy
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No prior hematopoietic stem cell transplantation
Chemotherapy
- See Disease Characteristics
Endocrine therapy
- Not specified
Radiotherapy
- See Disease Characteristics
- No prior radiotherapy to the liver or adjacent organs
Surgery
- Not specified
Other
- No concurrent aspirin or nonsteroidal anti-inflammatory medications such as ibuprofen (e.g., Motrin® or Advil®)
- No other concurrent phase I study enrollment
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00062140
Locations
| United States, Washington | |
| Fred Hutchinson Cancer Research Center | |
| Seattle, Washington, United States, 98109-1024 | |
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
Investigators
| Study Chair: | George B. McDonald, MD | Fred Hutchinson Cancer Research Center |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00062140 History of Changes |
| Other Study ID Numbers: | 1797.00, FHCRC-1797.00, CDR0000304522 |
| Study First Received: | June 5, 2003 |
| Last Updated: | September 20, 2010 |
| Health Authority: | United States: Federal Government |
Keywords provided by Fred Hutchinson Cancer Research Center:
|
recurrent adult diffuse large cell lymphoma recurrent adult diffuse mixed cell lymphoma recurrent adult diffuse small cleaved cell lymphoma recurrent adult Burkitt lymphoma recurrent adult Hodgkin lymphoma recurrent adult immunoblastic large cell lymphoma recurrent adult lymphoblastic lymphoma recurrent cutaneous T-cell non-Hodgkin lymphoma recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent grade 3 follicular lymphoma recurrent mantle cell lymphoma noncontiguous stage II adult diffuse large cell lymphoma noncontiguous stage II adult diffuse mixed cell lymphoma noncontiguous stage II adult Burkitt lymphoma |
noncontiguous stage II adult immunoblastic large cell lymphoma noncontiguous stage II adult lymphoblastic lymphoma noncontiguous stage II grade 3 follicular lymphoma noncontiguous stage II mantle cell lymphoma stage III adult lymphoblastic lymphoma stage IV adult lymphoblastic lymphoma stage III adult Burkitt lymphoma stage IV adult Burkitt lymphoma recurrent adult acute myeloid leukemia untreated adult acute myeloid leukemia accelerated phase chronic myelogenous leukemia blastic phase chronic myelogenous leukemia chronic phase chronic myelogenous leukemia meningeal chronic myelogenous leukemia relapsing chronic myelogenous leukemia |
Additional relevant MeSH terms:
|
Leukemia Lymphoma Lymphoma, Non-Hodgkin Myelodysplastic Syndromes Preleukemia Myeloproliferative Disorders Lymphoma, Large-Cell, Immunoblastic Myelodysplastic-Myeloproliferative Diseases Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Bone Marrow Diseases |
Hematologic Diseases Precancerous Conditions Cyclophosphamide Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists |
ClinicalTrials.gov processed this record on May 22, 2013